MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-01-30 for ULTHERA SYSTEM manufactured by Ulthera, Inc., Merz Device Innovation Center.
[177180269]
No contact information for the patient or treating practice were provided; therefore, attempts to obtain additional information regarding the patient/treatment details/device information was not possible. As device information was not provided, evaluation of the actual device(s), device history record review, and service history review could not be performed. An analysis of the ultherapy patient complaint trending for the reported issues of "patient other" and "burns" revealed that the frequencies of both issues are within allowable limits and will continue to be monitored. No further information is available at this time. If additional information is received, a supplemental medwatch form will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[177180270]
On 08-jan-2020, merz/ulthera received a report via fda medwatch form regarding an ultherapy adverse event. Per the form provided; the reporter alleged, "ultherapy; promoted off-label, false advertising, hid what it was. Had life threatening unseen reaction. I went into an altered mental state. Lost all of my faculties, was suffocating, skin and mucous membranes cooked off. Wound up with severe brain damage. Was cooked alive as the burns were of an electrical nature. Coming from the constipated seizure i was in. Cure was large doses of gabapentin. Because i was not helped, i am disabled, with brain damaged. " no contact information for the reporter or the practice that performed the ultherapy treatment was provided; therefore, attempts to acquire additional information regarding this event are not possible. No additional information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006560326-2020-00001 |
| MDR Report Key | 9649459 |
| Report Source | OTHER |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-06 |
| Date of Event | 2015-05-21 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT WDOWICKI |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal | 85204 |
| Manufacturer Phone | 2628355300 |
| Manufacturer G1 | ULTHERA, INC., MERZ DEVICE INNOVATION CENTER |
| Manufacturer Street | 1840 SOUTH STAPLEY DRIVE SUITE 200 |
| Manufacturer City | MESA AZ 85204 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85204 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTHERA SYSTEM |
| Generic Name | ULTHERA SYSTEM |
| Product Code | OHV |
| Date Received | 2020-01-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTHERA, INC., MERZ DEVICE INNOVATION CENTER |
| Manufacturer Address | 1840 SOUTH STAPLEY DRIVE SUITE 200 MESA AZ 85204 US 85204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |